Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02075047 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Terminated
- Registry status
- Phase 3
- Development phase
- 171
- Enrollment target
NCT02075047: Clinical Trial Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT02075047 is a Phase 3 study that was terminated before completion, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 171 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02075047, a Phase 3 study, was terminated before completion, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 171 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
Primary Outcome
YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of man
Interventions
- DRUG placebo oral capsules
- DRUG ziprasidone oral capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2014-05-23 |
| Est. Completion | 2020-05-18 |
| Phase | Phase 3 |
Why NCT02075047 stopped before completion
NCT02075047 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo oral capsules is the first listed.
NCT02075047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02075047 about?
NCT02075047 is a clinical study titled "Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder". The purpose of this study is to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
What is the current status of trial NCT02075047?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 171 participants. The study started on 2014-05-23. Estimated completion is 2020-05-18.
What interventions are being tested in trial NCT02075047?
The interventions under investigation include: placebo oral capsules (DRUG), ziprasidone oral capsules (DRUG).
Who is sponsoring clinical trial NCT02075047?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02075047's enrollment target sits among peer trials
171 1451st of 2000 higher than 548 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02641145 · 171 participants · NA
Molecular Imaging of Primary Amyloid Cardiomyopathy
- NCT05541029 · 171 participants · NA
Music Listening: A Mechanistic Trial
- NCT05561127 · 171 participants · Phase 3
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
- NCT05592938 · 171 participants · NA
Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI